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| |  Natalizumab Benefit in Crohn's Disease Patients Not Dependent on Immunosuppressant Use: Presented at UEGW By Jill Stein PARIS, FRANCE -- October 29, 2007 -- The induction of sustained response and remission in patients with Crohn's disease (CD) does not require concurrent immunosuppressive therapy, according to data released at the 15th United European Gastroenterology Week (UEGW). Martina Spehlmann, MD, assistant professor of gastroenterology, Asklepios Westklinikim Hamburg, Hamburg, Germany, presented results of the Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) trial in a presentation on October 29. In the study, induction of sustained response with natalizumab was comparable in patients who did and who did not receive concomitant immunosuppression. The data are from an analysis that assessed the efficacy of natalizumab in the ENCORE subpopulation of patients who did not receive concomitant immunosuppressants, defined as azathioprine, mercaptopurine, and methotrexate, throughout the study. "The use of other biological agents as therapy for CD may require concomitant use of immunosuppressants to limit the development of antibodies to drug product, which is often associated with a risk of allergic reactions and reduced efficacy," Dr. Spehlmann observed. In the phase 3 ENCORE trial, 509 patients with active disease and evidence of inflammation were randomised to receive natalizumab or placebo at weeks 0, 4, and 8. The primary endpoint was the ability of natalizumab to induce a clinical response by the week 8 that was sustained through week 12. The trial stipulated that immunosuppressants be continued throughout the trial consistent with baseline use. Overall, 315 patients were not taking immunosuppressants at baseline and thus received natalizumab or placebo without concomitant immunosuppression. The remaining 194 patients received concomitant immunosuppression during the trial. In patients who did not receive concomitant immunosuppressants, the treatment effect was evident as early as the first assessment (week 4). Response rates at week 4 were 53% for patients on natalizumab and 36% for patients on placebo (P =.003). The response rate at weeks 8 was 56% and 62% at week 12. Fifty percent of natalizumab-treated patients experienced a sustained response through weeks 8 and 12, which was significant compared with the 32% of placebo patients (P =.001). In patients who did not receive concomitant immunosuppression, remission was sustained through weeks 8 and 12 in 23% of natalizumab-treated patients and in 16% of placebo patients (P =.033). Remission rates at the week 8 and 12 time points were 30% and 38% in the natalizumab cohort versus 22% and 28% in the placebo cohort (P <=.55 for both comparisons with placebo). Natalizumab improved quality of life and was well tolerated whether or not patients received concomitant immunosuppressants. Incidence of adverse events and infections was similar with and without concomitant immunosuppressant therapy. "The data demonstrate that response and remission were durable in natalizumab compared with placebo-treated patients irrespective of immunosuppressant use," Dr. Spehlmann commented. Funding for this study was provided by Elan Pharmaceuticals, Inc. and Biogen Idec, Inc.
[Presentation Title: Natalizumab does Not Require the Concomitant Use of Immunnosuppressants for the Induction of Sustained Response and Remission in Crohn's Disease Patients. Abstract G-364]
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